Hemostasis connectors are well known in various surgical procedures, being used for access to the arterial system of a patient in angioplasty and angiography procedures. Also, hemostasis connectors may be used in conjunction with atherectomy procedures, the administration of laser catheters to the arterial system, and the like.
Typically, an elongated member such as an atherectomy device, a laser catheter, or a PTCA balloon catheter passes through a tubular hemostasis connector which carries a hemostasis seal, through which the elongated member penetrates within the tubular connector. In some circumstances, the hemostasis seal may be a slit elastomeric partition, which permits the passage of a catheter or the like, but seals around it, and also seals in the absence of the elongated member to prevent back bleeding due to arterial or flushing pressure.
In other hemostasis connectors, the hemostasis seal device is of the Tuohy-Borst type, in which a valve or gasket opening is variably adjusted in diameter. The Tuohy-Borst type of structure comprises a tubular, elastomeric member having a central opening therethrough, and a screw threaded member which can be advanced to adjustably pressurize the elastomeric member, with the result that the central opening is of variable size, depending upon the degree of pressurization. Thus, in this latter type of device, a catheter or the like may pass through the adjustable valve opening, with the diameter of the opening then being reduced or clamped down onto the catheter for a tight hemostasis seal. Such adjustable hemostasis valves are often used for larger catheters and other elongated members of a size of typically French 9 or larger, such as arthrectomy devices, laser catheters, and the like.
However, as a disadvantage of the adjustable, variable hemostasis connector valves, while they seal tightly against back bleeding due to arterial pressure, flushing, or the like, a catheter or other device passing through the valve is not advanced or retracted with ease while the adjustable valve is providing such good sealing. Thus, typically, the surgeon is forced to release the sealing pressure on the catheter passing through the adjustable valve for adjustment of the position of the catheter, sliding it through the valve to a different position. During this period of time, substantial back bleeding or other leakage can take place.
In accordance with this invention, a hemostasis connector is provided which is capable of adjustable valved sealing of a catheter or other elongated member passing therethrough, but when the sealing is released to facilitate movement of the catheter through the valve, back leakage is greatly suppressed. Thus, a valve is provided in which substantial pressures of flushing of x-ray contrast fluid or the like can be utilized without back leakage or back bleeding, but the device readily permits the sliding adjustment of the catheters, atherectomy devices, and the like passing through it.